Bang Kiem Tra Checklist Va Huong Dan Kiem Tra Danh Gia Co So Giet Mo Lon AP Dung Gmps

D THO 2: HNG DN KIM TRA, NH GI

(TN C QUAN KIM TRA)

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc

BIN BN KIM TRA QUY TRNH THC HNH SN XUT TT

(GMP) I VI C S GIT M LN

I. THNG TIN CHUNG:

1. Tn c s:

2. a ch:

3. S in thoi: S Fax:

4. M s (nu c):

5. Ngy kim tra:

6. Hnh thc kim tra:

7. Thnh phn on kim tra: 1) .............................................................................................................

2) .............................................................................................................

3) .............................................................................................................

8. i din c s: 1) ........................................................................................................

2) ........................................................................................................ ............................................................................

II. CH TIU KIM TRA:

TTCh tiu kim traKt qu nh giLi vi phm v hnh ng khc phc

tKhng t

Ac)(Mi)(Ma) (Se) (Cr)

1. C s h tng v trang thit b

1.1. a im

1V tr ca c s git m co tun th k hoch s dng t ca a phng v c c quan c thm quyn cp phep khng ?[ ][ ]1

2V tr ca c s git m c xa khu dn c, xa cc ngun gy nhim khng?[ ][ ]1

3C s git m c c xy dng ni c ngun cung cp in, cung cp nc n nh khng?[ ][ ]1

1.2. Thit k v b tr

1.2.1 Thit k tng th

4C s git m ln c tng ro bao quanh hoc cch bit vi khu vc xung quanh khng? C s git m ln c h st trng ti mi cng ra vo khng? [ ][ ]

5C s git m ln c h thng x l cht thi rn v cht thi lng khng?[ ][ ][ ]1

6C s git m ln c c thit k thnh 4 khu ring bit gm khu tn tr, git m, khu vc hnh chnh v khu x l cht thi khng?[ ][ ]1

1.2.2.Khu git m

7Th t cc hot ng trong khu git m c lu thng theo mt chiu t khu bn n khu sch khng?[ ][ ]1

8Tng pha trong c c lt bng vt liu nhn, chng thm, d v sinh, kh trng v cao t nht 2m khng?[ ][ ][ ]

9Trn/ mi khu git m ln c cao thch hp khng? C thit b git m treo, trn c cao hn thit b treo t nht l 1m khng?[ ][ ]1

10Sn ca khu git m ln c c lm bng vt liu bn, khng thm nc, nhn, chng trn trt, d v sinh, sn c b ng nc khng?[ ][ ]1

11Khu git m c c trang bi nh sng theo mc yu cu khng? [ ][ ][ ]1

12Bng n c li bc bo v khng?[ ][ ]

1.2.3. Thot nc v cht thi

13C h thng cng thu gom nc thi gn khu vc xung ln v chung nui nht ln khng. H thng cng thu gom nc thi c np y khng?[ ][ ]

14H thng thot nc thi cua c s git m co u cng sut v hiu qu khng? [ ][ ]

15H thng that nc thi ca c s git m c ring bit vi that nc ma v nc thi t toilet khng? [ ][ ]2

16Nc thi trc khi thi ra mi trng c m bo cc tiu chun k thut theo quy nh hin hnh khng?[ ][ ]2

17C s c duy tr hat ng qun l ph ph phm trong l m theo quy chun s QCVN 01-25:2009/BNNPTNT khng? [ ][ ]2

1.2.3. Khu chung tn tr

18Ni nhp ln c trang thit b m bo vic bc d ng vt an ton trnh gy thng tch cho ng vt git m khng?[ ][ ]2

19Chung nui nht ln trc khi git m c mi che khng?, nn c lt bng xi mng hoc cc cht liu chng trn trt, d thot nc, d v sinh tiu c khng?[ ][ ]1

20Chung c th nui nht c h thng cung cp nc cho ln ung v nc tm ra cho ln, c khu cch ly ln m khng?[ ][ ]2

1.6. Tin nghi v nh v sinh

21C phng v sinh v phng thay qun o cho cng nhn khng?[ ][ ]

22Phng v sinh v phng thay qun o cho cng nhn c cch bit hon ton vi khu vc sn xut , ca phng v sinh khng c m thng vo khu sn xut khng?[ ][ ]2

23Tin nghi v nh v sinh c trong tnh trng hot ng tt , sch s, c kh trng v t yu cu v sinh khng? [ ][ ]

1.8. H thng kho

24C khu vc bo qun qun o bo h, thit b vt t c nhn c tch bit khu git m khng?[ ][ ]

2

25C khu vc bo qun d tr dng c git m, ha cht dng v sinh c s khng ? [ ][ ]

[ ]

2

1.9. Nc

26Ngun cung cp nc cho tt c cc hot ng sn xut nh git m, lm sch v v sinh c v s lng, nhit v p sut khng?[ ][ ]

1

27Nc s dng cho cc hot ng git m v lm sch c ph hp vi quy nh ca B Y t khng?[ ][ ]1

28Nc c c phn tch t nht 2 ln/nm khng? H s c c lu li khng? [ ][ ]

1

29C bo dng v lm sch h thng cung cp nc khng?[ ][ ]

1

2.0. Trang thit b v bo dng

2.1. Thit b

30Bn, dng c, dng s dng cho git m c c lm bng vt liu bn, khng r, khng thm nc, khng n mn, khng c khng? [ ][ ]

1

31Dng c v dng c c s dng ring r cho mi khu vc git m, ring r thng cha cc sn phm n c (tim, gan) v cc sn phm km v sinh x l khng?[ ][ ]

1

32Dao v dng c ct tht c c bo qun ni quy nh trong l m khng ? [ ][ ]

33Dao v dng c ct tht c c v sinh trc v trong khi thao tc khng?[ ]

34C s c chng trnh bo dng nh k cc thit b tip sc vi tht bo m cc thit b ny khng b nhim khng ? [ ][ ]

2.2. Bo dng

35Vic bo dng, sa cha cc thit b, my mc c c tin hnh sau ca sn xut khi tht c chuyn i ht trnh nhim khng? [ ][ ]2

3. V sinh

3.1. Chng trnh v sinh (SOP # 3)

36C quy trnh tiu c kh trng trong l m (bao gm: s dng ho cht, nng ; quy trnh TKT cc thit b, my mc, tn sut) khng? [ ][ ]1

37Trc mi ca sn xut c kim tra li vic lm sch, v sinh kh trng nh xng, thit b, dng c khng ? [ ][ ]

38Trc mi ca sn xut, cc thit b dng cho git m v pha lc tht nh dao v dng c ct c c lm sch bng nc sch c cht ty trng v v sinh khng?[ ][ ]1

4. Kim sot cn trng v ng vt gy hi (SOP # 6 a, b)

39C chng trnh v bin php hu hiu chng cn trng v ng vt gy hi khng? [ ][ ]1

40C nui chim, ch, mo v bt k ng vt no khc trong khu git m khng?[ ][ ]1

5. Nhn s (SOP # 5)

5.1. Yu cu v sc khe

41C s git m c vn bn qui nh v sc kho i vi cng nhn lin quan trc tip n qu trnh sn xut thc phm, cc vn bn qui phm v v sinh c nhn khng ? [ ][ ]1

42Nhng ngi b bnh truyn nhim c tip xc trc tip vi tht khng?[ ][ ]2

43Nhng ngi c vt thng h c c bng b bng vt liu chng thm khng? [ ][ ]1

5.2. V sinh c nhn1

44Cng nhn tip sc trc tip vi tht c c trang b bo h lao ng theo quy nh khng? [ ][ ]

45Cng nhn lm vic c duy tr v sinh c nhn trong sut qu trnh lm vic khng ? [ ][ ]1

46C chng trnh tp hun v chng trnh tp hun c m bo cho tt c cc cng nhn trong c s git m ln phi hot ng v vn hnh ng quy trnh khng? [ ][ ]1

47Xe vn chuyn gia sc n l m c theo quy nh khng? [ ]

[ ]

1

48Ln c c chuyn n c s git m t nht 6 gi trc khi git m khng? [ ][ ]1

6.0. Kim sot qu trnh git m

6.1. Tip nhn ln

49Tip nhn gia sc c theo quy nh khng ?

( Q 87/2005/BNN&PTNT ngy 26/12/2005)

[ ][ ] bi 4

8.2. Kim tra ln trc khi git m

50Kim tra gia sc trc khi git m gia sc c theo quy nh khng?

( Q 87/2005/BNN&PTNT ngy 26/12/2005)

[ ][ ][ ]bi 4

8.3. Lm sch ln v chch in trc khi git m

51Tt c ln c c tm ra trc khi git m khng?[ ][ ]

1

52C chch sc in, ln trc khi git m v thi gian ly tit ln c ng k thut khng?[ ][ ][ ]1

8.4. Lt ph tng: CCP 1BC (SOP# 7)

53Vic lt ph tng c c thc hin trn gi treo hay trn gi cao hn mt sn t nht 30 cm khng?[ ][ ]

54Qu trnh lt ph tng c c thc hin v kim sat nhm m bo mc nhim nm trong gii hn kim sat hay khng? [ ][ ]

8.5. Kim tra sau git m

55Tt c thn tht v ph tng c c kim tra bi cn b Th y khng?[ ][ ][ ]

56Mt phn hay ton b thn tht, khng t tiu chun c c x l theo quy nh khng?[ ][ ]

8.6. Ra ln cui (thn tht, u v ph tng)

57Qu trnh ra ln cui, c ti liu yu cu cho im kim sot ti hn v c thc hin, kim sat nhm m bo mc nhim nm trong gii hn kim sat hay khng? [ ][ ]

8.7. ng du hoc ln du kim sot git m, dn tem v sinh th y

58C ng du kim sat git m v cp giy chng nhn kim dch theo quy nh khng? [ ][ ]Bi 4

7.Vn chuyn

59Xe v thng xe cha tht c c lm sch, kh trng trc v sau khi vn chuyn theo quy trnh m bo tht khng b nhim bi cht ty ra hay cht c hi khng?[ ][ ]1

60Trc khi khi hnh, sn phm c c Th y kim tra theo quy nh v ngi li xe c chu trch nhim cung cp thng tin php l t ngi bn hng ti ngi mua hng khng?[ ][ ]1

8. Qun l

61C s git m c thnh lp i chu trch nhim xy dng v thc hin chng trnh thc hnh sn xut tt theo HACCP khng?[ ][ ]1

9.Kim tra, khiu ni v ti liu

62Tt c ti liu lin quan c c lu gi theo yu cu ca nh chc trch ti thiu l 2 nm khng?[ ][ ]2

63C s git m c ghi chp tt c cc khiu ni ca khch hng khng? [ ][ ]2

Tng s6394856

II. KT LUN CA ON KIM TRA:

III.C s xp loi

. NHN XT V KIN NGH CA ON KIM TRA:

V. KIN CA I DIN C S:

....................., ngy thng nm

...................., ngy thng nm I DIN C S C KIM TRA TRNG ON KIM TRA

(K tn, ng du)

(K tn)HNG DN KIM TRA, NH GI THC HNH SN XUT TT (GMP) I VI C S GIT M LN TI VIT NAM

I. nh ngha cc mc li1. Li ti hn (Cr): L sai lch so vi tiu chun, gy mt an ton thc phm, tc ng xu n mi trng, nh hng ti sc kho ngi tiu dng.

2. Li nghim trng (Se): L sai lch so vi tiu chun, nu ko di s gy mt an ton thc phm, tc ng xu n mi trng nhng cha ti mc ti hn.

3. Li nng (Ma): L sai lch so vi tiu chun, c th nh hng n an ton thc phm, tc ng xu n mi trng nhng cha ti mc nghim trng.

4. Li nh (Mi): L sai lch so vi tiu chun gy tr ngi cho vic kim sot v sinh nhng cha n mc nng.

II. S dng biu mu kim tra

- Khng c b sung hoc b bt ni dung, mc nh gi c quy nh trong mi ch tiu.

- Vi mi ch tiu, ch xc nh mc sai li ti cc ct c k hiu [ ], khng c xc nh mc sai li vo ct khng c k hiu [ ].

- Dng k hiu ( hoc ( nh du vo v tr mc nh gi c xc nh i vi mi ch tiu (mi ch tiu ch xc nh 1 mc li).

- Phi din gii chi tit li c xc nh cho mi ch tiu v thi hn c s phi khc phc li .

Hng dn c s dng kim tra vic tun th cc yu cu ATVSTP mt hoc nhiu ni trong c s. Nu cn b kim tra quyt nh l c s p ng cc iu kin v sinh mt khu vc c th trong c s, th qui trnh ny cn phi dn chng trong k hoch qui trnh nh thc hin. Cn b kim tra s dng kin thc chuyn mn v phn quyt ca mnh a ra quyt nh liu cc yu cu v ATVSTP c c p ng hay khng. Cn b kim tra nh gi iu kin trong c s sau quyt nh liu cc iu kin c gy ra cc tnh trng mt v sinh dn n tp nhim sn phm hay khng hoc c ngn cn vic kim tra ca ngi kim tra khng. iu ny c ngha l c th c mt s iu kin cha hon ho nhng cng khng hn l cha p ng cc yu cu qui nh v chng khng to ra cc iu kin mt v sinh, tp nhim sn phm hoc ngn cn cc hot ng kim tra.

II. HNG DN PHNG PHP KIM TRA, NH GI QUY TRNH SN XUT TT (GMP) TRONG C S GIT M LN

1. A IM 1.1. Ch tiu 1: V tr xy dng c s git m c ph hp vi quy hoch s dng t ca a phng v c c quan c thm quyn cp phep khng? (A- 1 mc li ti hn).Tham kho GMP s 7.11.1.1. Yu cu: V tr xy dng c s git m phi ph hp vi quy hoch s dng t ca a phng v c c quan c thm quyn cp phep. 1.1.2. Phng php: Xem xt giy chng nhn quyn s hu t, giy cp t, hp ng thu t, h s quy hoch c cp c thm quyn ph duyt hoc vn bn cho php hot ng do c quan c thm quyn cp.1.1.3. nh gi: Ph hp vi 1.1.1 nh gi t (Ac):

C s git m phi ph hp vi quy hoch s dng t ca a phng. Hoc c cc c quan qun l nh nc c thm quyn cho php. y h s. Khng ph hp vi 1.1.1 nh gi li ti hn (Cr).

1.2. Ch tiu 2: V tr ca c s git m c xa khu dn c, xa cc ngun gy nhim khng? (A - 1 mc li ti hn).Tham kho GMP s 7.11.2.1. Yu cu: V tr ca c s git m phi xa khu dn c, xa cc ngun gy nhim, khng trong vng nh hng ca bi khi, ha cht c hi ca nh my, x nghip.1.2.2. Phng php: Xem kt qu thm nh mi trng ca c quan chc nng, h s quy hoch c cp c thm quyn ph duyt v kim tra thc t.

1.2.3. nh gi:

Ph hp vi 1.2.1 nh gi t (Ac): Khong cch t c s git m n trng hc, bnh vin, khu dn c, ni thng xuyn tp trung ng ngi, ng giao thng chnh, ngun nc mt ti thiu 100m;

Cch tri chn nui, ch bun bn ln ti thiu 1 km. Kt qu thm nh mi trng ca c quan chc nng v mi trng nh gi t yu cu.

Khng ph hp vi 1.2.1.nh gi li ti hn (Cr).

1.3. Ch tiu 3: C s git m c c xy dng ni c ngun cung cp in, cung cp nc n nh ? (A- 1 mc li Se ).Tham kho GMP s 7.11.3.1. Yu cu: C s git m phi c xy dng ni c ngun cung cp in, cung cp nc n nh .

1.3.2. Phng php: Xem h s thit k v kim tra thc t.

- Kim tra ngun nc

1.3.3. nh gi:

Ph hp vi 1.3.1. nh gi t (Ac): C s git m phi c xy dng ni c ngun cung cp in, cung cp nc n nh Khng ph hp vi 1.3.1: nh gi li ti hn (Se).

1.4. Ch tiu 4: C s git m ln c tng ro bao quanh hoc cch bit vi khu vc xung quanh, c li ra vo xut nhp gia sc v c tri b tng v c h st trng ti mi cng khng? (A- 1 mc li nng ).Tham kho GMP s 7.21.4.1. Yu cu: C s git m ln phi c tng ro bao quanh hoc cch bit vi khu vc xung quanh, c li ra vo ring xut nhp gia sc v c tri b tng ,c h st trng ti mi cng ra vo.1.4.2. Phng php: Xem h s thit k v kim tra thc t.

1.4.3. nh gi:

Ph hp vi 1.4.1. nh gi t (Ac):

C s git m ln phi c tng ro bao quanh hoc cch bit vi khu vc xung quanh, c li ra vo ring xut nhp gia sc v c tri b tng v c h st trng ti mi cng ra vo Khng t c im no ca 1.4.1. nh gi li ti hn (Ma).

1.5. Ch tiu 5: C s git m ln phi c h thng x l cht thi rn v cht thi lng khng? (A- 1 mc li nng ).Tham kho GMP s 7.41.5.1. Yu cu: C s git m ln c h thng s l cht thi rn v cht thi lng. Sn nh phi dc v pha h thng nc thi; ng nc thi phi c ng knh t nht 20cm v c np y bo v; Hng dng chy ca nc thi t khu vc sch n khu vc bn; H thng x l nc thi nh (biogaz, h sinh hc) phi b tr di hng gi; B lng phi c th tch gp 2 ln khi lng nc s dng trong ngy. 1.5.2. Phng php: Xem h s thit k v kim tra thc t, phng vn v sinh vin trong c s, xem xt h s ghi chp.

1.5.3. nh gi:

Ph hp vi 1.5.1. nh gi t (Ac):

Khng c h thng x l cht thi lng v rn: nh gi li ti hn (Ma).

1.6. Ch tiu 6: C s git m ln c c thit k thnh 4 khu ring bit gm khu sch, khu bn , khu vc hnh chnh v khu x l cht thi? (A- 1 mc li Ma). ( 7.4)

1.6.1. Yu cu: C s git m ln phi c thit k thnh 4 khu ring bit gm , khu sch, khu bn, khu x l cht thi v khu hnh chnh; Tham kho GMP s 7.21.6.2. Phng php: Xem h s thit k v kim tra thc t.

1.6.3. nh gi:

Ph hp vi 1.6.1. nh gi t (Ac)

Khng t 1.6.1: nh gi (Ma)

1.7. Ch tiu 7: Th t cc hot ng trong c s git m ln c lu thng theo mt chiu t khu bn n khu sch.? (A- Ma ).Tham kho GMP s 7.21.7.1. Yu cu: Th t cc hot ng trong c s git m ln phi lu thng theo mt chiu t khu bn n khu sch: tn tr - khu tm ln - khu gy sc, - ly huyt - co lng - moi ph tng - ra - ch thn tht v khm tht.1.7.2. Phng php: kim tra thc t qu trnh git m.

1.7.3. nh gi:


Khng t 1.7.1: hat ng ty tin, lm lng chung trong khu x tht; nh gi (Ma)

1.8. Ch tiu 8: Tng pha trong khu git m ( nu c) c c lt bng vt liu nhn, khng thm nc, d v sinh kh trng v cao t nht 2m khng? (A- 1 mc li nng ). Tham kho GMP s 7.2)1.8.1. Yu cu: Tng pha trong khu git m phi lt bng vt liu nhn, khng thm nc, d v sinh, kh trng v cao t nht 2m; 1.8.2. Phng php: Xem h s thit k v kim tra thc t.

1.8.3. nh gi:


Khng ph hp vi 1.8.1. nh gi t (Ma)

1.9. Ch tiu 9: C s git m ln c chiu cao ca trn/ mi v cao mc treo theo quy nh khng ? (A- 1 mc li nng).Tham kho GMP s 7.21.9.1. Yu cu: C s git m ln phi c trn/ mi khu vc git m cao 3,6m; khu vc pha lc tht, khm cao 3m; khu vc un nc nng v lm lng cao 4,8m . khu vc c thit b git m treo tht , trn phi cao hn thit b treo t nht l 1m.1.9.2. Phng php: Xem h s thit k v kim tra thc t.

1.9.3. nh gi:



1.10. Ch tiu 10: Sn ca khu git m ln c lm bng vt liu bn, khng thm nc, nhn, khng trn trt, d lm sch, dc v h thng thu gom cht thi khng ng nc, cht thi khng ? (A- 1 mc li nng ).Tham kho GMP s 7.21.10.1. Yu cu: Sn ca khu git m ln phi lm bng vt liu bn, khng thm nc, nhn, chng trn trt, d lm sch, dc v h thng thu gom cht thi khng ng nc, cht thi.1.10.2. Phng php: Xem h s thit k v kim tra thc t.

1.10.3. nh gi:



1.11. Ch tiu 11: Khu git m c c trang bi nh sng theo yu cu khng ? (A- 2 mc li nh, ln ). Tham kho GMP s 7.3

1.11.1. Yu cu: Cng nh sng phi t yu cu: Khu vc git m, khu vc pha lc tht: 300Lux; Khu vc kim tra tht x, u v ni trng 500Lux; Khu vc ng gi, khu tn tr : 200Lux1.11.2. Phng php: kim tra thc t ( Lux meter)

1.11.3. nh gi:


Khng t yu cu nh sng khu kim tra ca cn b l m: nh gi (Ma)

Khng t yu cu nh sng khu khc: nh gi (Mi)

1.12. Ch tiu 12: Bng n trong c s git m ln c c bc li bo v ngn nga nh hng khi n v khng ? (A- 1 mc li nng). Tham kho GMP s 7.31.12.1. Yu cu: Bng n trong c s git m ln phi c bc li bo v ngn nga nh hng khi n v

1.12.2. Phng php: kim tra thc t.

1.12.3. nh gi:


Khng c li bo v n: nh gi (Ma)

1.13. Ch tiu 13: C h thng cng thu gom nc thi gn khu vc bc d gia sc v chung nui nht gia sc. H thng cng thu gom nc thi c np y khng? (A- 1 mc li nng ). Tham kho GMP s 7.41.13.1. Yu cu: C h thng cng thu gom nc thi gn khu vc bc d gia sc v chung nui nht gia sc. H thng cng thu gom nc thi phi c np y. 1.13.2. Phng php: Xem h s thit k v kim tra thc t.

1.13.3. nh gi:



1.14. Ch tiu 14: H thng thot nc thi cua c s git m co u cng sut v hiu qu khng? (A- 1 mc li nng ).

1.14.1. Yu cu: H thng thot nc thi vn hnh tt trong qu trnh lm v sinh c s git m v v sinh xe vn chuyn gia sc: khng c hin tng khng thot ht nc trong khi git m ( ngay c khi git m cng sut ti a);1.14.2. Phng php: Xem h s thit k v kim tra thc t.

1.14.3. nh gi:


Nc khng thot ht trong khi git m: nh gi (Ma)

1.15. Ch tiu 15: H thng thot nc thi ca c s git m c ring bit vi thot nc ma v nc thi t toilet khng? (A- 1 mc li nng )Tham kho GMP s 7.1 1.15.1. Yu cu: H thng thot nc thi ca c s git m phi ring bit vi thot nc ma v nc thi t toilet.1.15.2. Phng php: Xem h s thit k v kim tra thc t.

1.15.3. nh gi:



1.16. Ch tiu 16: Nc thi trc khi thi ra mi trng c m bo cc tiu chun k thut theo quy nh hin hnh khng ? (A- 1 mc li Cr).

1.16.1. Yu cu: Nc thi trc khi thi ra mi trng phi m bo cc tiu chun k thut theo quy nh hin hnh; cng thot nc thi u ra d tm thy. (Quy chun k thut quc gia QCVN: 24-2009/BTNMT) GMP #7.41.16.2. Phng php: kt qu xt nghim mu nc thi, c th ly mu nc thi u ra xt nghim nu cn thit.

1.16.3. nh gi:


Khng t 1.16.1: nh gi (Cr)

1.17. Ch tiu 17: C s c duy tr hat ng qun l ph ph phm trong l m theo quy chun s QCVN 01-25:2009/BNNPTNT khng?(A-1 mc li nng). Tham kho GMP s 7.41.17.1. Yu cu: Thng ng ph ph phm phi c np y v v c nh du theo chc nng s dng. Ph ph phm, cht thi trong qu trnh git m phi c thu dn thng xuyn trong mi ca lm vic v c dn sch sau mi ca lm vic .1.17.2. Phng php: kim tra thc t.

1.17.3. nh gi:


Khng t 1.17.1: nh gi (Ma): Ph ph phm khng c thu dn thng xuyn trong mi ca lm vic v khng c dn sch sau mi ca lm vic

1.18. Ch tiu 18: Ni nhp ng vt c trang thit b m bo vic bc d ng vt an ton trnh gy thng tch cho ng vt git m khng ? (A- 1 mc li nng ).Tham kho GMP#7

1.18.1. Yu cu: Ni nhp ng vt phi c trang thit b m bo vic bc d ng vt an ton trnh gy thng tch cho ng vt git m.1.18.2. Phng php: quan st, kim tra thc t.

1.18.3. nh gi:



1.19. Ch tiu 19: Chung nui nht ln trc khi git m c mi che, nn c lt bng cht liu chng trn trt, d thot nc, d v sinh tiu c khng ? (A- 1 mc li nh).Tham kho GMP#7.5 1.19.1. Yu cu: Chung nui nht ln trc khi git m phi c mi che, nn phi lt bng cht liu chng trn trt, d thot nc, d v sinh tiu c, kh trng.1.19.2. Phng php: kim tra thc t.

1.19.3. nh gi:



1.20. Ch tiu 20: Chung nui nht ln trc khi git m c h thng cung cp nc cho ln ung v tm ra cho ln khng ? (A- 1 mc li nng ).Tham kho GMP#7.5

1.20.1. Yu cu: Chung nui nht ln trc khi git m phi c h thng cung cp nc cho ln ung v tm ra cho ln .


1.20.3. nh gi:


Khng t 1.20.1: nh gi (Ma):

1.21. Ch tiu 21: C s git m ln c phng v sinh v phng thay qun o cho cng nhn khng ? (B - 1 mc li ln ).Tham kho GMP#7.6

1.21.1. Yu cu: C s git m ln phi c phng v sinh v phng thay qun o cho cng nhn, phng phi, sy kh bo h lao ng v dng c v sinh .


1.21.3. nh gi:



1.22. Ch tiu 22: Nh v sinh v phng thay qun o cho cng nhn c cch bit hon ton vi khu vc sn xut v khng c m ca trc tip vo khu sn xut khng ? (A - 1 mc li nng ).Tham kho GMP#7.6 1.22.1. Yu cu: Nh v sinh v phng thay qun o cho cng nhn cch bit hon ton vi khu vc sn xut v khng c m ca trc tip vo khu sn xut


1.22.3. nh gi:



1.23. Ch tiu 23: Tin nghi v nh v sinh c trong tnh trng hot ng tt , sch s, c kh trng v t yu cu v sinh khng? (A - 1 mc li nng).Tham kho GMP#7.6 1.23.1. Yu cu: Nh v sinh c trang b nh sng, khng kh lu thng tt, trang b cc dng c v sinh, trong tnh trng hot ng tt v sch s .


1.23.3. nh gi:



1.24. Ch tiu 24: C khu vc bo qun qun o bo h v ti sn c nhn v khu vc c phi tch ri khu git m khng ?(A li nh ).

1.24.1. Yu cu: C khu vc bo qun qun o bo h v ti sn c nhn v khu vc c phi tch ri khu git m.


1.24.3. nh gi:


Khng t 1.24.1: nh gi (Mi)

1.25. Ch tiu 25: C khu vc bo qun d tr dng c git m, ha cht dng v sinh c s khng ? (A - 2 mc li nh hoc ln ).

1.25.1. Yu cu: C khu vc bo qun d tr dng c git m, ha cht dng v sinh c s ; kho phi cao ro sch s, khng b m mc, ngn chn c ng vt gy hi; khng b dt, tt nc; thng thong(A- 2 nh hoc ln)Tham kho GMP#7.8

1.25.2. Phng php: kim tra thc t kho d tr

1.25.3. . nh gi: Ph hp vi 1.25.1. nh gi t (Ac)

Khng t 1.25.1 v ha cht : nh gi (Ma)

Khng t bo qun dng c: nh gi (Mi)

1.26. Ch tiu 26: Ngun nc cung cp nc cho tt c cc hot ng sn xut nh lm sch v v sinh c v s lng, nhit v p sut khng ? (A - 1 mc li nng ).Tham kho GMP s 7.91.26.1. Yu cu: Ngun nc cung cp nc cho tt c cc hot ng sn xut nh lm sch v v sinh c v s lng, nhit v p sut

1.26.2. Phng php: kim tra thc t

1.26.3. nh gi:



1.27. Ch tiu 27. Nc s dng cho cc hot ng git m v lm sch c ph hp vi quy nh hin hnh khng ? (A - mc li ti hn).Tham kho GMP s 7.9 v quy chun QCVN01/2009-BYT; SOP#2

1.27.1. Yu cu: Nc s dng cho cc hot ng git m v lm sch c ph hp vi quy nh hin hnh (QCVN 01/2009 - BYT ).

1.27.2. Phng php: kim tra phiu xt nghim, c th ly mu nu nghi ng..

1.27.3. nh gi:


Khng t c ch tiu vi sinh vt, l ha: nh gi (Cr)

1.28. Ch tiu 28. Nc c c phn tch t nht 2 ln/nm khng? H s c c lu li khng? (A - 1 mc li nng ).Tham kho GMP#7.9/ SOP #21.28.1. Yu cu: Nc phi c phn tch t nht 2 ln/nm khng? H s c lu li y (bao gm ngun ly mu, kt qu phn tch v cc bin php khc phc)

1.28.2. Phng php: Xem h s .

1.28.3. nh gi:



1.29. Ch tiu 29. C quy trnh bo dng v lm sch h thng cung cp nc khng ? (A - 1 mc li nh).Tham kho GMP#7.9

1.29.1. Yu cu: C quy trnh bo dng v lm sch h thng cung cp nc; c h s lu li nhng ln bo dng v khc phc, sa cha km theo.

1.29.2. Phng php: Xem h s

1.29.3. nh gi:


Khng bo dng, khng c h s: nh gi (Mi)

1.30. Ch tiu 30. Bn, dng c v dng s dng cho git m c c lm bng vt liu bn, khng r, khng n mn, khng c ? (A - mc li nng).Tham kho GMP#8.1

1.30.1. Yu cu: Bn, dng c v dng s dng cho git m phi c lm bng vt liu bn, khng r, khng n mn, khng c

1.30.2. Phng php: Kim tra thc t.

1.30.3. nh gi:



1.31. Ch tiu 31. Dng c v dng c c s dng ring cho mi khu vc git m. S dng ring thng cha cho cc sn phm n c (tim, gan) v cc sn phm km v sinh x l khng ? (B - 1 mc li nng ).Tham kho GMP#8.1

1.31.1. Yu cu: Dng c v dng phi c s dng ring cho mi khu vc git m. S dng ring thng cha cho cc sn phm n c (tim, gan) v cc sn phm km v sinh x l.

1.31.2. Phng php: kim tra thc t, phng vn cng nhn.

1.31.3. nh gi:



1.32. Ch tiu 32. Dao v dng c ct tht c c bo qun ni quy nh trong l m khng ? (A - 1 mc li nng ).Tham kho GMP#8.1

1.32.1. Yu cu: Dao v dng c ct tht phi c bo qun ni quy nh trong l m khng c mang v nh hoc ch bun bn


1.32.3. nh gi:



1.33. Ch tiu 33. Dao v dng c ct tht c c v sinh trc v sau khi thao tc khng ? (A - 1 mc li nng ).Tham kho GMP#8.1 SOP #31.33.1. Yu cu: Dao v dng c ct tht phi c v sinh trc v sau khi thao tc.

1.33.2. Phng php: kim tra thc t thc hnh ca cng nhn.

1.33.3. nh gi:



.

1.34. Ch tiu 34. C s c chng trnh bo dng nh k cc thit b tip sc vi tht bo m cc thit b ny khng b nhim khng ? (A - 1 mc li nng ).Tham kho GMP#8.2 SOP #3

1.34.1. Yu cu: C s git m ln phi c chng trnh bo dng nh k cc thit b tip sc vi tht (bao gm danh mc cc thit b, tn xut kim tra. Quy trnh bo dng v thi im bo dng phi ph hp.

1.34.2. Phng php: Xem h s v kim tra thc t, phng vn cng nhn

1.34.3. nh gi:



1.35. Ch tiu 35. Vic bo dng, sa cha cc thit b, my mc c c tin hnh sau ca sn xut khi tht c chuyn i ht trnh nhim khng? (A - 1 mc li nng ).Tham kho GMP#8.21.35.1. Yu cu: Vic bo dng, sa cha cc thit b, my mc phi c tin hnh sau ca sn xut khi tht c chuyn i ht trnh nhim 1.35.2. Phng php: kim tra thc t.

1.35.3. nh gi:


Khng t 1.35.1. nh gi t (Ma)

1.36. Ch tiu 36. C quy trnh tiu c kh trng trong l m (bao gm: s dng ho cht, nng ; quy trnh TKT cc thit b, my mc, tn sut) khng? (A - 1 mc li nng).Tham kho GMP#9.1 SOP #3

1.36.1. Yu cu: C quy trnh tiu c kh trng trong l m (bao gm: s dng ho cht, nng ; quy trnh TKT cc thit b, my mc, tn sut cho tng i tng trong qu trnh git m).

1.36.2. Phng php: kim tra quy trnh v sinh c c s vit v xem xt thc t.

1.36.3. nh gi:


Khng c quy trnh theo 1.36.1. nh gi t (Ma)

1.37. Ch tiu 37. Trc mi ca sn xut c kim tra li vic lm sch, v sinh kh trng nh xng, thit b, dng c khng ? (A - 1 mc li nng).

1.37.1. Yu cu: Trc mi ca sn xut phi kim tra li v sinh nh xng, thit b, dng c. H s th hin cc phng php v kt qu kim tra v sinh, cc bin php khc phc trc khi git m.

1.37.2. Phng php: Xem h s v kim tra thc t, c th ly mu kim tra

1.37.3. nh gi:



1.38. Ch tiu 38. Trc mi ca sn xut, cc thit b dng cho git m v pha lc tht nh dao v dng c ct c c lm sch bng nc sch c cht ty trng v v sinh khng?

1.38.1. Yu cu:Trc mi ca sn xut, cc thit b dng cho git m v pha lc tht phi c lm sch bng nc sch c cht ty trng v v sinh

1.38.2. Phng php: quan st thc t, kim tra s sch ghi chp

1.38.3. nh gi: Ph hp vi 1.38.1. nh gi t (Ac)


1.39. Ch tiu 39. C s git m c chng trnh v bin php hu hiu chng cn trng v ng vt gy hi khng ? (A - 1 mc li nng ).Tham kho GMP#10.1 SOP #4

1.39.1.Yu cu: C s git m phi c chng trnh bng vn bn v bin php hu hiu chng cn trng v ng vt gy hi. m khng nh hng n an ton thc phm

1.39.1. Phng php: Xem h s v kim tra thc t xem c s xut hin ca cn trng hay s lm t ca cn trng, chut b

1.39.2. nh gi:


Khng c chng trnh v bin php: nh gi (Ma)

1.40. Ch tiu 40. C nui chim, ch, mo v bt k ng vt no khc trong khu chn nui khng ? (A - 1 mc li nng).Tham kho GMP#10.4 1.40.1. Yu cu: Khng c nui chim, ch, mo v bt k ng vt no khc trong khu git m.


1.40.3. nh gi:


Nui ng vt khc trong l m: nh gi (Ma)

1.41. Ch tiu 41. C s git m c vn bn qui nh v sc kho i vi cng nhn lin quan trc tip n qu trnh sn xut thc phm v cc vn bn qui phm v v sinh c nhn khng ? (A - 1 mc li nng).Tham kho GMP#11.1 v quy nh ca BYT

1.41.1. Yu cu: C s git m phi c vn bn qui nh v sc kho i vi cng nhn lin quan trc tip n qu trnh sn xut thc phm, cc vn bn qui phm v v sinh c nhn .

1.41.2. Phng php: Xem h s v kim tra thc t.

1.41.3. nh gi:


Khng c vn bn quy nh: nh gi (Ma)

1.42. Ch tiu 42. Nhng ngi b bnh truyn nhim c tip xc trc tip vi tht khng? (A - 1 mc li nng).

1.42.1. Yu cu: Nhng ngi b bnh truyn nhim khng c tip xc trc tip vi tht .1.42.2. Phng php: Xem h s v kim tra thc t.

1.42.3. nh gi:


Khng ph hp 1.42.1.: nh gi (Ma)

1.43. Ch tiu 43. Nhng ngi c vt thng h c c bng b bng vt liu chng thm khng? (A - 1 mc li nng).

1.43.1. Yu cu: Nhng ngi c vt thng h phi c bng b bng vt liu chng thm 1.43.2. Phng php: Xem h s v kim tra thc t.

1.43.3. nh gi:



1.44. Ch tiu 44. Cng nhn tip sc trc tip vi tht c c trang b bo h lao ng theo quy nh khng? (A - 1 mc li nng ).

1.44.1. Yu cu: Cng nhn c c trang b bo h lao ng theo quy nh cho tng i tng: Cng nhn git m, ly lng, pha lc, v sinh tiu c kh trng.


1.44.3. nh gi:


Khng ph hp vi 1.44.1: nh gi (Ma)

1.45. Ch tiu 45. Cng nhn lm vic c duy tr v sinh c nhn trong sut qu trnh lm vic khng ? (A - 1 mc li nng).tham kho GMP # 11.21.45.1. Yu cu: Cng nhn lm vic c duy tr v sinh c nhn trong sut qu trnh lm vic;Bo h phi c lm sch sau mi ca sn xut; c n ung, ht thuc, khc nh trong khu vc sn xut; ra tay trc khi thao tc, sau khi h mi, ho v n ung, sau khi i v sinh v sau khi cm nm nhng vt liu b nhim 1.45.2. Phng php: kim tra thc t.

1.45.3. nh gi:


Vi phm bt c yu cu no trong 1.45.1 (Ma)

1.46. Ch tiu 46. C chng trnh tp hun v chng trnh tp hun c m bo cho tt c cc cng nhn trong c s git m ln phi hot ng v vn hnh ng quy trnh khng? (A - 1 mc li nng). tham kho GMP # 11.31.46.1. Yu cu: Phi c chng trnh tp hun v chng trnh tp hun phi m bo cho tt c cc cng nhn trong c s git m ln phi hot ng v vn hnh ng quy trnh

1.46.2. Phng php: Xem h s tp hun v kim tra thc t.

1.46.3. nh gi:



1.47. Ch tiu 47. Xe vn chuyn gia sc n l m c theo quy nh khng? (A-li nh) tham kho 10TCN 8711.47.1. Yu cu: Xe vn chuyn gia sc n l m c theo quy nh bo m v mt , kn, khng gy thng tch cho ln

1.47.2. Phng php: quan st v kim tra thc t

1.47.3. nh gi:



Kim sat git m

Kim sat trc git m

1.48. Ch tiu 48. Ln c c chuyn n c s git m t nht 6 gi trc khi git m khng? (A-li nh) tham kho GMP#1.48.1. Yu cu: Ln phi c chuyn n c s git m t nht 6 gi trc khi git m

1.48.2. Phng php: Kim tra thc t

1.48.3. nh gi Ph hp vi 1.48.1. nh gi t (Ac)

Khng t 1.48.1. nh gi t (Mi)

1.49. Ch tiu 49. Tip nhn gia sc c theo quy nh khng ? (A - 1 mc li nh).

1.49.1. Yu cu: Phi tip nhn gia sc c theo quy nh: c trang thit b m bo vic bc d gia sc an ton; chuyn n c s git m t nht 6 gi trc khi git m; thao tc nh nhng i vi gia sc; Nht ln khng qu cht chi trong cc chung khc nhau.


1.49.3. nh gi:


Khng t 1.49.1. nh gi (Mi)

1.50. Ch tiu 50. C kim tra gia sc trc khi git m gia sc theo quy nh khng ? (A - 2 mc li nng, nghim trong ).Q 87/2005/BNNPTNT date 26th December 2005)?1.50.1. Yu cu: Phi thc hin ng quy trnh kim tra gia sc trc khi git m gia sc: phi c Th y vin kim tra giy t, triu chng lm sng; gia sc eo s tai vi ni dung c kim tim b gy, phi c nht ring v phi git m u tin.


1.50.3. nh gi:


Khng kim tra gia sc eo s tai kim tim b gy, nht ring v khng thc hin vic git m lai gia sc ny u tin: nh gi (Ma)

1.51. Ch tiu 51. Tt c gia sc c c tm ra trc khi git m khng ? (A - 1 mc li nng). Tham kho GMP #14.31.51.1. Yu cu: Tt c gia sc phi c tm ra trc khi git m.


1.51.3. nh gi:


Khng tm ra gia sc trc khi git m: nh gi (Ma)

1.52. Ch tiu 52. C chch sc in gia sc trc khi git m, thi gian ly tit c ng k thut khng? (A - 2 mc li nng, nh ).Tham kho GMP #14.31.52.1. Yu cu: Phi chch sc in gia sc trc khi git m; thi gian chch sc khng qu 15 giay; trnh chch in ti khu vc mt, b phn sinh dc v vng hu mn. Thi gian ly hyt khng qu 2 giy.


1.52.3. nh gi:


Khng chch sc in gia sc trc khi git m hoc ly tit qu 20 pht: nh gi (Ma)

C chch in nhng chch in ti khu vc mt, b phn sinh dc v vng hu mn: nh gi (Mi)

Lt ph tng CCP 1B(SOP#7)

1.53. Ch tiu 53. Vic lt ph tng c c thc hin trn gi treo hay trn gi cao hn mt sn t nht 30 cm khng? (A - 1 mc li nghim trng).Tham kho GMP #14.4 CCP 1B(SOP#7)

1.53.1. Yu cu: Vic lt ph tng phi c thc hin trn gi treo hay trn gi cao hn mt sn t nht 30 cm.


1.53.3. nh gi:


Khng lt ph tng trn gi treo hay trn gi cao hn mt sn t nht 30 cm: nh gi (Cr)

1.54. Ch tiu 54. Qu trnh lt ph tng c c thc hin v kim sot nhm m bo mc nhim nm trong gii hn kim sot hay khng? (A - mc li ti hn).Tham kho GMP #14.4; SOP#7; CCP 1B1.54.1. Yu cu: Qu trnh lt ph tng c c thc hin v kim sot nhm m bo mc nhim nm trong gii hn kim sot: Phi c h s, ti liu hng dn qu trnh kim sot trong qu trnh lt ph tng; c nhm k tht theo di, gim st v hng dn thc hin theo yu cu ca chng trnh; Mc nhim vt gii hn cho php (trn 5% nhim trong s 60 thn tht), phi p dng cc bin php khc phc gim nhim

1.54.2. Phng php: kim tra thc t v kim tra h s ( SOP#7 v mu 7)

1.54.3. nh gi:


Vi phm mt trong cc li trn: nh gi (Cr)

Kim sot sau git m

1.55. Ch tiu 55. Tt c thn tht, u v ph tng c c kim tra bi Th y vin khng? (A - 2 mc li nng, nghim trng ).

1.55.1. Yu cu: Tt c thn tht, u v ph tng phi c kim tra bi Th y vin theo quyt nh 87/BNNPTNT

1.55.2. Phng php: Xem h s , phiu ghi chp v kim tra thc t.

1.55.3. nh gi:


Khng kim tra thn tht, u, ph tng: nh gi (Se)

Khng kim tra ph tng, u nh gi (Ma)

1.56. Ch tiu 56. Mt phn hay ton b thn tht, khng t tiu chun v sinh lm thc phm c c x l theo quy nh ca Php lnh th y khng? (A - 1 mc li nghim trng).

1.56.1. Yu cu: Mt phn hay ton b thn tht, khng t tiu chun v sinh lm thc phm c c x l theo quy nh ca Php lnh th y.


1.56.3. nh gi:


Khng thc hin theo 1.56.1. nh gi (Se)

Ra ln cui

1.57. Ch tiu 57. Qu trnh ra ln cui, c ti liu yu cu cho im kim sot ti hn v c thc hin, kim sot nhm m bo mc nhim nm trong gii hn kim sot hay khng? (A - 1 mc li ti hn).GMP 14.6; SOP# 81.57.1. Yu cu: Phi c ti liu, hng dn yu cu cho im kim sot ti hn v duy tr vic thc hin, kim sot nhm m bo mc nhim nm trong gii hn kim sot. Nu mc nhim vt gii hn cho php, c p dng cc bin php khc phc ph hp

1.57.2. Phng php: Xem h s mu ghi chp v kim tra thc t.

1.57.3. nh gi:


Khng c ti liu yu cu cho im kim sot v khng thc hin vic kim sot: nh gi (Cr)

1.58. Ch tiu 58. C ng du kim sot git m v cp giy chng nhn kim dch theo quy nh khng? (A - 1 mc li nng).87/BNN)/SOP #121.58.1. Yu cu: Phi ng du, ln du kim sot git m hoc dn tem v sinh th y i vi thn tht, ph tng n c sau khi git m tiu chun v sinh th y v cp giy chng nhn kim dch theo quy nh.


1.58.3. nh gi:


Khng thc hin theo 1.58.1. nh gi li (Ma)

1.59. Ch tiu 59. Xe v thng xe cha tht c c lm sch, kh trng trc v sau khi vn chuyn theo quy trnh khng (A - 1 mc li nng).GMP 13.3; SOP#3

1.59.1. Yu cu: Xe v thng xe cha tht phi c lm sch, kh trng trc v sau khi vn chuyn m bo rng tht khng b nhim bi cht ty ra hay cht c hi; thng xe phi kn, khng tip xc vi khng kh bn ngai; Khng c dng xe vn chuyn tht v ph tng n c vn chuyn gia sc, gia cm sng v cc i tng khc.

1.59.2. Phng php: Kim tra thc t.

1.59.3. nh gi:


Khng t 1.59.1: nh gi (Se)

1.60. Ch tiu 60. Trc khi khi hnh, sn phm c c Th y kim tra theo quy nh v ngi li xe c chu trch nhim cung cp thng tin php l t ngi bn hng ti ngi mua hng khng? (A - 1 mc li nng ).

1.60.1. Yu cu: Trc khi khi hnh, sn phm phi c Th y kim tra theo quy nh v ngi li xe phi chu trch nhim cung cp thng tin php l t ngi bn hng ti ngi mua hng .

1.60.2. Phng php: Xem h s vn chuyn v quan st thc t.

1.60.3. nh gi:

Ph hp vi 1.60.1. nh gi (Ac)

Khng thc hin: nh gi (Ma)

1.61. Ch tiu 61. C s git m c thnh lp i hoc ngi chu trch nhim xy dng v thc hin chng trnh thc hnh sn xut tt GMP khng? (A - 1 mc li nng).

1.61.1. Yu cu: C C s git m phi thnh lp i hoc c ngi chu trch nhim xy dng v thc hin chng trnh thc hnh sn xut tt GMP theo HACCP: c s git m phi chnh thc c t nht mt ngi chu trch nhim v chng trnh GMP vi vai tr l iu phi vin HACCP, chu trch nhim v vic chnh sa v bin tp GMP v h thng cht lng; kim tra sn phm v p dng cc bin php khc phc; phi hp vi cc nh chc trch a phng; c d n FAPQDCP o to chnh thc.


1.61.3. nh gi:


Khng thnh lp i chu trch nhim xy dng v thc hin chng trnh thc hnh sn xut tt HACCP: nh gi (Ma)

1.62. Ch tiu 62. Tt c ti liu lin quan c c lu gi theo yu cu ca nh chc trch ti thiu l 2 nm khng? (A - 1 mc li nng ).

1.62.1. Yu cu: Tt c ti liu lin quan phi c lu gi theo yu cu ca nh chc trch ti thiu l 2 nm.


1.62.3. nh gi:


Khng lu gi ti liu, nh gi (Ma)

1.63. Ch tiu 63. C s git m c ghi chp tt c cc khiu ni ca khch hng khng ? (A - 1 mc li nh ).

1.63.1. Yu cu: C s git m c ghi chp tt c cc khiu ni ca khch hng .


1.63.3. nh gi:


C s git m khng ghi chp cc khiu ni ca khch hng, khng c quy trnh thu hi sn phm, nh gi (Mi)

III. Hng dn x l kt qu nh gi1. Xp loi c s:

LiXp loiNh (Mi)Nng (Ma)Ng/trng (Se)Ti hn (Cr)

A 5 10 00

BKhng tnh 15 30

CKhng tnh 25 50

DKhng tnhKhng tnh 5Hoc 1

2. X l kt qu:

2.1. T chc chng nhn ( third party body) x l kt qu:

2.1.1. Trng hp kim tra ln u, kim tra li (kim tra chng nhn):

Ch c s xp loi A mi c cp chng nhn GMP.

2.1.2. Trng hp kim tra gim st, kim tra t xut (kim tra duy tr, gia hn chng nhn):

C s xp loi A c tip tc duy tr, gia hn chng nhn GMP.

C s xp loi B c tip tc duy tr, gia hn chng nhn GMP nhng b nhc nh.

C s xp loi C b T chc Chng nhn ra Quyt nh nh ch chng nhn GMP.

C s xp loi D b T chc Chng nhn ra Quyt nh thu hi chng nhn GMP.

2.2. C quan qun l x l kt qu (Authority officers):

C quan qun l yu cu T chc Chng nhn tip tc duy tr, gia hn chng nhn GMP nu C s xp loi A.

C quan qun l yu cu T chc Chng nhn tip tc duy tr, gia hn chng nhn GMP v ra vn bn thng bo nhc nh c s nu C s xp loi B.

C quan qun l yu cu T chc Chng nhn ra Quyt nh nh ch chng nhn GMP nu C s xp loi C.

C quan qun l yu cu T chc Chng nhn ra Quyt nh thu hi chng nhn GMP nu C s xp loi D.

IV. X l vi phm I VI C S GIT M

1. Nhc nh: T chc Chng nhn nhc nh bng vn bn n c s git m khi xp loi B. Khi b nhc nh, c s phi tho thun vi T chc chng nhn v thi hn khc phc sai phm v phi c hnh ng khc phc ng thi hn. Sau khi khc phc sai li, c s phi gi thng bo bng vn bn v T chc Chng nhn.

2. nh ch chng nhn: C s git m b T chc Chng nhn ra Quyt nh nh ch chng nhn GMP trong nhng trng hp sau y:

a) C s xp loi C (theo kt qu kim tra ca c quan qun l hoc kt qu kim tra gim st, kim tra t xut ca T chc Chng nhn);

b) C s b nhc nh khng khc phc sai li ng thi hn.

T chc Chng nhn ra Quyt nh nh ch chng nhn GMP v quy nh thi hn nh sn xut khc phc sai li.

3. Thu hi chng nhn: C s chn nui b T chc Chng nhn ra Quyt nh thu hi chng nhn GMP trong nhng trng hp sau y:

a) C s xp loi D (theo kt qu kim tra ca c quan qun l hoc kt qu kim tra gim st, kim tra t xut ca T chc Chng nhn);

b) Khng c hnh ng khc phc sai li ng thi hn sau khi b nh ch chng nhn GMP;

c) T chi kim tra ca T chc Chng nhn;

d) Xin hon kim tra ca T chc Chng nhn 02 (hai) ln lin tip khng c l do chnh ng;

e) S dng logo GMP khng ng vi ni dung vn bn u quyn s dng logo GMP.

Trong thi hn 1 nm k t ngy c Quyt nh thu hi chng nhn GMP c hiu lc, c s sn xut khng c chng nhn GMP.7

Bang Kiem Tra Checklist Va Huong Dan Kiem Tra Danh Gia Co So Giet Mo Lon AP Dung Gmps

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